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临床试验/NCT07040488
NCT07040488招募中不适用

Study of Infrared Thermography in Diabetic Foot in Guadeloupe (ETPDG)

Centre Hospitalier Universitaire de la Guadeloupe1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年9月27日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
temperatures at four areas of the plantar surface of the foot

研究概览

简要总结

It is hypothesized that thermal imaging differs between diabetic and non-diabetic individuals in Guadeloupe. Infrared thermography is also suggested as a useful tool for studying diabetic foot ulceration. The main objective is to compare the temperatures of four areas of the plantar surface of the foot among non-diabetic individuals, diabetic individuals, and diabetic individuals with foot ulceration.

详细描述

Diabetes represents a major public health issue in the region. Among its most severe complications is diabetic foot ulceration, which frequently results in amputation. Infrared thermography is a non-invasive and non-ionizing imaging technique that provides precise temperature data at specific points on the body. When combined with 3D imaging technologies, infrared thermography may offer early diagnostic potential for infections related to diabetic foot ulcers, by revealing both visible and subclinical signs. A preliminary step in assessing the relevance of thermal imaging is to determine whether thermographic patterns differ between the feet of diabetic and non-diabetic individuals within the Guadeloupean population, particularly in a tropical climate. Currently, international guidelines do not recommend infrared thermography as part of routine clinical practice for managing diabetic foot ulceration. However, this imaging modality could potentially contribute to the diagnostic arsenal for infections associated with diabetic foot ulcers.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

temperatures at four areas of the plantar surface of the foot

时间窗: baseline

The primary outcome is the measurement of temperatures in degrees Celsius (°C) using infrared thermography (coupled with a 3D camera) at four areas of the plantar surface of the foot: the pulp of the hallux, the heel, the heads of the first and fifth metatarsals, and at the site of the diabetic foot ulcer.

次要结局

  • Temperatures on the same area of the contralateral foot(baseline)

研究者

发起方
Centre Hospitalier Universitaire de la Guadeloupe
申办方类型
Other
责任方
Sponsor

研究点 (1)

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